Regulatory guidance for clinical research and human tissue

6 January 2010

The UK Human Tissue Authority (HTA) has recently released new information about consent and the use of DNA via its website. The HTA is a public body established under the Human Tissue Act 2004 that licenses organisations that store ands use human tissue for different purposes including research, medical treatment, post-mortem examination and education, in England, Wales and Northern Ireland.

The website brings together information on consent including the HTA Code of practice on Consent, frequently asked questions, a glossary, policy information on non-consensual DNA analysis (and how to apply for this via the HTA), and two flowcharts on Consent and the use of DNA and Qualifying consent.

The Medical Research Council (MRC) also provides an online Data and Tissues Tool Kit, developed in conjunction with the HTA and other relevant bodies, that offers help and guidance on legislative requirements and good practice with respect to the use of human tissue and personal information for healthcare research in the UK (see previous news).

With respect to broader health research, the UK Clinical Research Collaboration (UKCRC) recently released a new booklet on the changing regulatory and governance environment for clinical research, outlining new measures intedned to reduce bureaucracy and streamline research. The UKCRC is a partnership of stakeholders including academia, industry, funders, regulators, patients and the NHS established to redesign the clinical research environment with a view to improving national health and wealth.

The Health Services Research Network has also recently produced a briefing document describing changes in the research governance landscape.

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